Tag Archives: CMS

While there are plenty of valid reasons to be skeptical about the Affordable Care Act, regardless of where you fall on the political spectrum, it’s hard to argue that imposing an individual mandate to purchase insurance won’t result in more people obtaining coverage. According to the results of a recent survey conducted by the Centers for Disease Control and Prevention (CDC), that’s precisely what’s happened. Based on results of the National Health Interview Survey, researchers at the CDC estimate that nearly 4 million people gained insurance coverage from January to March of 2014. Of course, we also know that people tend to procrastinate, and that consequently, there was a surge of last-minute sign-ups occurring in March. Those newly insured individuals aren’t accounted for in the CDC’s findings, and other estimates that include those individuals put the number of newly insured at between 8 and 10 million. Even then, as Jonathan Gruber is quoted saying in the New York Times, “This is really a three-year process of implementation….Trying to draw strong conclusions from one quarter of one year is impossible.” The bottom line is: The early indications are that more people have coverage, and things seem to be moving in the right direction. But let’s not get ahead of ourselves.

According to another report, though, the end of the third quarter may bring a slight uptick to the number of uninsured. Apparently, Uncle Sam has actually been checking on the information people submitted through Healthcare.gov when they signed up for coverage. As it turns out, the Centers for Medicare and Medicaid Services (CMS) found that nearly 1 million people had issues documenting their status as U.S. citizens. Most of these people were citizens, complied with requests to submit proper documentation, and have kept their coverage. But there are still 115,000 people who have failed to submit documentation by the government’s September 5th deadline. As I’m writing this, these people have two weeks to get their documentation in order. If they do not do so by September 30th, they will lose their coverage. On top of this, more than 350,000 other people–who are unquestionably U.S. citizens–may lose their federal subsidies that lowered the cost of their insurance, because they didn’t submit verifiable proof of income to the government. Together, this represents nearly one-half million people that could be at risk of going without insurance once again after only part of a year.

The issue is whether the discrepancies in documentation are accurate reflections of reality. If someone is an undocumented immigrant, the law is clear that they are not entitled to purchase health insurance through the exchange. Likewise, if someone makes more money than they claim, the law is clear that they are only entitled to the amount of subsidy that corresponds to their actual income. So, if the failure to provide verifiable documentation is legitimate, then by denying these individuals coverage, or eliminating their subsidy, the government is simply correcting a mistake it should not have made to begin with. That is, these people should never have qualified for coverage or a subsidy. However, we know all too well the technical issues that Healthcare.gov has experienced, and many people are claiming that they have tried to upload their documentation electronically without success. If the fault lies with a federal website that continues to experience glitches, it isn’t appropriate to deny people who are lawful residents of the U.S. and/or who have accurately reported their income to be denied coverage. Which is the case? I can only speculate, but I’d be willing to bet it’s a mixture of both. What I do know is that this is one more wrinkle in a complicated implementation process. But, to paraphrase Dr. Gruber, we’ve got at least two more years to iron things out.

With the release of their new HeartAssist5 heart pump, ReliantHeart is making real-time, personalized feedback possible for the millions of Americans suffering from heart failure. The new technology allows for real-time, remote monitoring of implantable devices, years of added life for patients, and flexibility to travel without a physician nearby. With a staggering projected 46% growth in heart failure by 2030, advances in heart failure innovation are on the forefront of changing medical treatment, policy, device research and physician reimbursements. Further, with heart failure and disease disproportionately affecting minorities in the US, advances in length and quality of life could be huge strides for medical equality.

Heart Failure In America

Approximately 7.5 million people in the United States currently suffer from heart failure, a figure that is increasing over time as more people survive heart attacks and various other heart conditions. According to the Heart Failure Society of America, an estimated 400,000 to 700,000 new cases of heart failure are diagnosed each year, with deaths averaging 250,000 annually, more than double since 1979. Even worse, an estimated one half of heart failure patients die within five years of diagnosis and 20% within the first year.

With a waiting list for heart transplants at an overwhelming 3,736 at publication, and less than 2,500 hearts donated annually, the need for a bridge between heart failure and transplant is literally life and death.

LVADs

Left ventricular assist devices (LVAD) are implantable heart pumps that were created to temporarily support patients with advanced heart failure as the bridge between diagnoses and transplant. However, with new scientific advancements, LVADs are becoming a long-term tool for improving heart function without transplant.

The right ventricle pumps blood to the lungs, but the left ventricle is responsible for pumping blood to the rest of the entire body, making it much more susceptible to failure. Therefore, LVADs have been the focus of most modern research to prolong and improve life saving implants.

Patient-Centered Care

Reliant’s system acts like your car’s dashboard. “If a patient’s pump has any sign of a challenge, like dehydration or low flow, the remote monitoring system signals the change to a data-collection center that notifies the transplant center as well as the individual,” ReliantHeart CEO Rodger Ford says. This is what makes the HeartAssist5 unique; at the first sign of a problem the right people are notified immediately.

Essentially, if the engine light goes on, the heart center and patient are notified to get the engine checked.

He also notes that the patients can set monitors to send text message notifications, thus making changes in blood flow, speed and power truly personalized. Individual blood flow is collected and transmitted every 5 minutes, making one’s own body the standard comparator.

The greatest importance to Founder and CTO Bryan Lynch is his ability to use his background as an engineer to, “Get involved in a project where you can actually see how you saved a life. While the docs and nurses are the real lifesavers, we give them the tool to make it possible.” He continues that it is vitally important for engineers and innovators to gain a patient-centered approach to get a real reduction in cost burden and improve quality of life.

Sailesh Saxena, CFO, continues highlighting the patient focus of the company by telling about the origination of the design of the VAD pack. “Bryan and I used to go to Schlotsky’s Deli ($BUNZ) for lunch,” he said, “and we used to see this man wearing a coat although it wasn’t cold out. Bryan noticed immediately that he was attempting to hide an LVAD controller and batteries. Well, this happened more than once, and we recognized that he was always concealing the VAD controller. So we decided that we needed to create a unique insert so that our LVAD control system could slip right into a Louis Vuitton ($LVMH) or Gucci ($GUC) bag unnoticed. It’s the small things that make the patient feel like we understand what they really want.”

Expanding The Geography Of Care

Remote monitoring, like other methods of telemedicine, is a key to expanding the geography of health care. “As technology matures, with the help of remote monitoring, the cardiologist and patient will feel safer with greater distances between them,” says Saxena.

This growth in telemedicine as a whole, and specifically in heart care, has major implications for the Centers for Medicare & Medicaid Services (CMS) as well as health care policy and reform. Because CMS is beginning to assign reimbursements and penalties based on patient outcomes instead of traditional fee-for-service metrics, it will become more and more important to have reimbursements reflect remote monitoring and its likely benefits.

Reimbursement codes also need to be reworked to genuinely target geographic discrepancies in care, which are fundamentally important for transplant centers. However, at present, CMS is slowly beginning to take growth rates of heart implants seriously based on the agency’s continued increases in payments, including their slight variations in geographic differences.

An Engineering Feat

In a recent study, researchers found that platelets flowing through the HeartAssist5 are exposed to significantly lower cumulative shear stress levels than in competitive devices tested. Ultimately, this means that the ReliantHeart product allows for what the CTO calls “a more physiologically normal cardiac output, including the pulse.”

What Bryan means is that people with failing hearts have low blood flow throughout the body, which is why they are so sick. When an LVAD is implanted, patients return to a more normal flow, but they also need blood flow that is as natural as possible. With the HeartAssist5, blood is not damaged and any pulse that the recovering heart produces is naturally transmitted to the body.

The LVAD and heart now work together to help the patient recover.

Although there are two other continuous flow LVADs on the market (THOR and HTRW), the ReliantHeart team claims their careful design capitalizes on working with the natural ventricle to the benefit of the patient, almost like a gym trainer for your heart.

Their “implantable flow probe” is also a revolutionary aspect of the HeartAssist5. This ultrasonic probe measures the blood flow from the LVAD in real-time providing critical feedback that is a one-of-a-kind technology providing data that makes the aforementioned remote monitoring so valuable. Ford says this ability to see patient-specific trends remotely in real time not only helps all patients improve quality of life, but the longevity of the HeartAssist5 creates a life support system, far beyond the “bridge” that the LVAD was originally created to be.

So this month, for American Heart Month, think about what innovation really is. It might be the ability to prolong and add quality of life for individuals and families across the nation, to share more time with loved ones.

There are many provisions in the Affordable Care Act that people don’t know about. Everybody is familiar with the health insurance part of it, but did you know the Centers for Medicare and Medicaid services (CMS) is giving $10 billion dollars to an organization called “The Innovation Center”? The Innovation Center is charged with researching ways to most effectively deliver health care. Good goal. The center’s website says “The Innovation Center develops new payment and service delivery models”. Oh. Well, still good goal.

Here’s what the definition of a “model” is, according the the free online dictionary: A schematic description of a system, theory, or phenomenon that accounts for it’s known or inferred properties and may be used for further study of its characteristics. So a model is not the thing. It’s a smaller or schematic representation of the thing. So what the Innovation Center is supposed to do is find or come up with schemes of payment and service delivery and try them out. It has been doing this, so far, largely with “demonstration projects”. A demonstration project tests an idea or group of ideas that might improve either payment systems or delivery systems, and then uses some complicated math to determine if things were better or worse before and after the idea is implemented. Therefore, CMS is not looking for proven methods of improving payment or services, but testing ideas that might work.

There’s nothing wrong with this, by itself. My 2-year-old does this all the time. She peers up at the kitchen counter, determines she can’t see, drags a chair over, gets on it, and compares the view with the chair vs. the view without the chair. Over time this has allowed her to develop a policy of always getting a chair if she wants to see what I’m doing. She wouldn’t go get the chair if I just said “be a good girl and go get a chair” and then praise her and give her a cookies if she does it. If you go the the Innovation Center website what you mostly see is incentive programs for good behavior. For example: The Comprehensive Primary Care Initiative is one of the Innovation Center’s projects. This is how CMS describes this program:

“The Comprehensive Primary Care (CPC) initiative is a multi-payer initiative fostering collaboration between public and private health care payers to strengthen primary care. Medicare will work with commercial and State health insurance plans and offer bonus payments to primary care doctors who better coordinate care for their patients. Primary care practices that choose to participate in this initiative will be given resources to better coordinate primary care for their Medicare patients.”

‘The PGP Demonstration was the first pay-for-performance initiative for physicians under the Medicare program. Under the PGP Demonstration, physician group practices continued to be paid under regular Medicare fee schedules, but earned incentive payments for offering patients high-quality, coordinated healthcare that resulted in Medicare savings for the patient population they served.”

Another, the Medicare Health Care Quality Demonstration, goes straight to performance measures. Three hospital/physician care systems in the US are being given money to test ideas that will improve performance measures. Performance measures are not “performance” measures. They are “quality” measures. Doctor’s get up on stage and perform certain things, and judges evaluate whether their performance is a quality one. As I have said before, measures of quality are things that are easily measured, quantifiable, and easy to find in an electronic medical record.

OK, to summarize so far: CMS, i.e the federal government, is funding the Innovation Center, which is supposed to find better ways to pay for and deliver health care, but which is mostly doing pay-for-performance stuff. Fine. There are some people doing some fine work in health care delivery who could use the funding. Some people are complaining that all the studies that the Innovation center are doing are demonstration studies, not randomized controlled trials (RCT). RCT’s are the medical gold standard for proof, essentially. It’s not true until an RCT says it is. Why isn’t the Innovation center doing more RCTs?

I postulate several reasons: 1. RCTs take a lot of time. CMS, under the gun from ACA opponents, wants quicker results. 2. A good RCT has a very narrow research question, usually one or maybe two interventions compared to no change. The researchers have to settle on a promising intervention and follow it up long-term. It’s hard to decide what promising intervention is going to give the best results given how long the question will take to answer. 3. There are so many moving parts in health care. It’s very hard to control for everything. Some large RCTs that have affected national policy, such as the Tennessee study in the 1980’s, which found that smaller class sizes in early childhood translated into better long-term outcomes, changed only one variable and kept everything else the same. Tennessee public schools are a closed system with relatively little short-term variability and relatively predictable human behaviors. An RCT that, for instance, studies the effect of a specific intervention on re-admission rates to hospitals has to deal with the variability of disease process and progression, human behavior, emergency situations, dubious quality measures, record-keeping inconsistencies, the list goes on and on.

So, should the Innovation center be doing RCTs? Absolutely. Is CMS funding the way to get that done? Probably not. But you have to give the ACA an A for effort on this one.

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Let’s talk about the Doc Fix. No it doesn’t mean that surgeons will get any less cranky or that your urologist will improve his bedside manner. What I am talking about in this case is the Sustainable Growth Rate formula. You see, the Center for Medicaid and Medicare Services, or CMS, has to figure out every year how much it’s going to pay for things. The SGR is supposed to ensure that as fees for everything in healthcare go up, the rate of increase does not outpace the growth of GDP. In a complicated middle-man maneuver, CMS sends a report to the Medicare Payment Advisory Commission, which in turn advises Congress on how much medicare spent last year and how much it’s targeted to spend next year. There is a conversion factor that adjust payments based on how much over or under the target cost was the previous year. The SGR is that conversion factor, and believe me unless you have the beautiful mind of John Nash you don’t want to know how it’s calculated. The SGR was formulated in 1997 and, put simply, is a way to control costs.

So the SGR is a formula to control medicare costs. OK. So what’s the problem? The problem is that as healthcare spending has outpaced GDP, every year since 2002 physician reimbursement has gone down. The SGR demands it, because every year cost is over the target. And every year Congress, under the heavy lobbying of the AMA, passes short-term overrides to prevent these cuts. And why is THIS a problem, since everything Congress does these days is emergency short-term fixes? Money. The gap between what the SGR says we should pay for medicare and what it actually costs is about $300 billion. The gap will get bigger and bigger. But what’s the alternative? Here’s what the Society for Hospital Medicine blog says:

“To earn greater or equal revenue, we will need to achieve prespecified process of care and health outcome targets (VBP or value-based payment) on top of the old reimbursement chassis. Additionally, participating in alternate payment models (APM’s), e.g., patient-centered medical homes, will garner increased rewards. A caveat, APM’s work for ambulists, but not for hospitalists—and SHM has responded to CMS with proposals. The same goes for VBP mismatches.”

What? I have no idea what most of that means but, as a physician, the phrase “we will need to achieve pre- specified process of care and health outcome targets” strikes fear into my heart and puts ice into my veins. You see, what Congress is suggesting is that instead of tying medicare payments to GDP, they should link the payments to quality measures or performance-based incentive programs. That would be great if there were anything like actual meaningful quality measurement metrics. Quality measurements have to be things that are easily understood numerically. Number of people counseled on smoking. Number of flu vaccines. Number of people getting pre-operative antibiotics. Number of time-outs before surgery. Number of people tested for prostate cancer. These are NOT measure of quality. They are measures of compliance by physicians who must blindly check boxes in order to ensure that their “quality” matches what a panel of experts say is quality. Not only do quality measures not measure quality, they impose the increasingly onerous documentation requirements physicians face every day.

“(Thursday’s) strong, bipartisan votes by the Senate Finance and House Ways and Means committees, following similar action last October by the House Energy and Commerce Committee, shows that there is overwhelming, bipartisan support for ending the SGR in a fiscally responsible manner and closing the book on the annual cycle of draconian Medicare physician payment cuts and short-term patches,” said Dr. Ardis Hoven, president of the American Medical Association. “This long-overdue policy change provides the stability that physicians need to pursue delivery innovations that help improve patient care and reduce costs for American taxpayers.”

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With notably few exceptions, the American health care system has been financed on the basis of volume rather than value. That means that we’ve been paying providers for everything that they do, rather than paying them for the outcomes they produce. This is not common in other fields. For example, if you are in an accident and have to take your car to a body shop, you (or your insurance company) typically pay them for the work once. If they haven’t repaired the vehicle properly, you can typically return the car to them and they will “make it right” for no additional charge. If you go out to eat, and the meal is not to your liking, the restaurant’s manager will typically offer to make you something else at no additional charge, or will discount the price of your unsatisfactory meal.

In health care, you pay the doctor to treat you, and if the treatment fails, you pay them to treat you again, and again, and again. Now, I’m not suggesting that this alone prompts physicians to do their job poorly or to provide more care than is necessary. Rather, I’m suggesting that the financial incentives are such that they do not reinforce physicians’ efforts to provide high quality care. Efforts to work around this include managed care and capitated payments, with the thinking that this shifts risk onto the providers and encourages them to doggedly pursue better outcomes. In some cases, this has worked. In other cases, it has backfired, as physicians simply reduce the amount of care they provide, much of it arguably needed care.

The latest development in this area is the implementation of financial penalties for hospitals with excessively high readmission rates among Medicare patients. As of October 2012, if a hospital’s readmission rate exceeds their expected readmission rate, they are fined by the Centers for Medicare & Medicaid Services (CMS). Right now, the maximum penalty is a 1% reduction in total Medicare payments over the coming year. By 2015, the penalty will increase to a maximum of 3%. This is a lot more money than it might seem from the percentage figures. In fact, it’s estimated to save Medicare roughly $300 million this year. That means, if hospitals don’t improve, CMS might keep nearly $1 billion a year starting in 2015.

Of course, the goal is to save even more money by using the penalty to encourage hospitals to prevent as many readmissions as possible. Medicare currently spends about $17 billion a year on readmissions, so there is considerable room for improvement and savings. However, I’m doubtful that the new penalties will achieve their desired effect. The reason is that hospitals have ways of artificially reducing their readmission rates. One prominent example is through the use of observation care, where patients are held in the hospital–sometimes for days–as outpatients. This is more costly for patients, who are responsible for a greater portion of their outpatient bills, it raises questions about the quality of care provided while a patient is under observation, and it seems like an ideal way for hospitals not to lose up to 3% of their Medicare reimbursement going forward. So, will penalizing hospitals for readmissions work? I doubt it. Not unless we find a way to prevent hospitals from working around the penalty.

In light of the recent election and the number of monumental decisions elected officials, government agencies, policymakers and health care providers have to make around health care reform, the Medicare program hasn’t been receiving much attention. However, given the sheer number of Americans covered by the program and the fiscal disaster looming for aging citizens, it is important to examine the state of the country’s care for the elderly and disabled.

In the United States, older women rely on the Medicare program disproportionality and significantly more than men. Not only do women make up more than half of the Medicare beneficiaries, they comprise about 70 percent of the oldest (over 85 years old) beneficiaries and are more likely to have multiple chronic conditions as they age. In 2010, the program, which is administered by the Centers for Medicare & Medicaid Services (CMS), covered 47 million elderly (age 65 and over) and disabled beneficiaries. Unfortunately for beneficiaries, the US Government Accountability Office (GAO) has designated Medicare a high-risk program due to its fiscally unsustainable path.

Because women have a greater likelihood of living longer than men, more health care conditions will accumulate and more health care costs accrue. This means that as women age increased cost sharing and out-of-pocket expenses directly impact them more. Therefore, given the importance of Medicare’s cost sharing with seniors, and its quickly dwindling resources, it is important to revisit how vital the program is to the elderly, especially older women.

Facts about older women on Medicare:

In 2010, the average American woman over the age of 65 had an annual income of less than $15,072 (compared to male counterparts at $25,704)

Women over the age of 80 made up 62% of all individuals with Medicare in 2010

In 2011, older women paid an average of $115 for the Medicare Part B premium, plus deductibles that range from $162 to $1132 before their benefits kicked in

In 2007, the average American women spent an estimated 18.7 percent of her income on out-of-pocket health care costs, with percentages increasing throughout the recession

Nationally, 49% of women with Medicare report having three or more chronic conditions (compared to just 38% of men)

Despite cost sharing measures, Medicare does not cover many common and costly health care needs such as eyeglasses, hearing aids and long-term care